Condition category
Not Applicable
Date applied
16/06/2020
Date assigned
19/06/2020
Last edited
23/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Rather than a one-time documentation of care goals and preferences, advance care planning (ACP) is currently conceptualized as an ongoing, communication process that should be initiated early in the disease trajectory. General practitioners (GPs) play a critical role in timely initiation of ACP. By discussing ACP with their GP, patients have time to think about and communicate their preferences, increasing their engagement with the process. However, little evidence exists of how GPs and patients can initiate these conversations effectively. In this project, we will conduct a randomized-controlled trial of an ACP intervention for general practice. We aim to compare the complex, multi-component ACP intervention to care as usual.

Who can participate?
Dutch-speaking GPs who treat patients in Flanders and Brussels, Belgium, are eligible to participate. GPs will identify which of their patients are eligible to participate. Eligible patients are adults (older than 18 years) with a chronic, life-limiting illness. Each patient may also indicate a surrogate decision maker for participation.

What does the study involve?
The intervention developed for this trial will be compared to a usual care control group. The intervention consists of the following components: 1) ACP knowledge and communication skills training for GPs, 2) a workbook about ACP for the patient, 3) at least 2 structured ACP conversations between the GP and patient, and 4) documentation of the ACP discussion in a template. A process evaluation with focus groups and interviews will be conducted to evaluate how the intervention was implemented. The control group GPs will provide their patients with the usual standard of care. No additional materials will be provided for this group, nor will additional ACP conversations be planned.

GPs, patients, and surrogate decision-makers in both groups will complete questionnaires at baseline, at 3 months, and at 6 months. The GP questionnaire will evaluate knowledge, attitudes, and self-efficacy regarding ACP, as well as the GP’s current ACP practices. The patient questionnaires will evaluate the patient’s level of engagement with ACP, quality of life, anxiety, and depression. Surrogate decision-maker questionnaires will evaluate the level of engagement with ACP.

What are the possible benefits and risks of participating?
This study can deliver valuable evidence about the effects of ACP in general practice, and of the effectiveness of the tools developed for this intervention. The training and tools presented to GPs and the workbook and conversations offered to patients can support GPs and patients in starting conversations about ACP. GPs in the control group will also be offered the chance to attend the training after the conclusion of the study.
There are minimal risks to participating. Patients are able to indicate what they wish to discuss ACP. We will also monitor patient depression and anxiety to allow a timely response to adverse events.

Where is the study run from?
The study is run from the Vrije Universiteit Brussels (VUB) and Ghent University (UGent) (Belgium)

When is the study starting and how long is it expected to run for?
The first participant is expected by 15/8/2020. The study will run until March 2021 (approximately 7 months).

Who is funding the study?
The Research Foundation - Flanders (Belgium) (Fonds Wetenschappelijk Onderzoek)

Who is the main contact?
1. Julie Stevens
Julie.joseph.stevens@vub.be
2. Prof. Koen Pardon
Koen.pardon@vub.e
3. Dr. Aline De Vleminck
Aline.de.vleminck@vub.be
4. Prof. Luc Deliens
Luc.deliens@vub.be

Trial website

Contact information

Type

Public

Primary contact

Miss Julie Stevens

ORCID ID

https://orcid.org/0000-0002-1417-0436

Contact details

End of Life Care Research Group
Brussels Health Campus - Building K
Laarbeeklaan 103
Jette
1090
Belgium
+32 470890527
julie.joseph.stevens@vub.be

Type

Scientific

Additional contact

Miss Julie Stevens

ORCID ID

https://orcid.org/0000-0002-1417-0436

Contact details

End of Life Care Research Group
Brussels Health Campus - Building K
Laarbeeklaan 103
Jette
1090
Belgium
+32 470890527
julie.joseph.stevens@vub.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2020/068

Study information

Scientific title

Improving patients’ level of engagement in advance care planning with their general practitioner: a cluster randomized controlled trial

Acronym

Study hypothesis

1. To compare the complex, multi-component advance care planning (ACP) intervention to care as usual in terms of their effect on:
1.1. the patient’s level of engagement with ACP (primary outcome at patient level)
1.2. the general practitioner (GP)’s self-efficacy for conducting ACP (primary outcome at GP level)
1.3. patient quality of life, symptoms of anxiety, symptoms of depression (secondary outcomes at patient level)
1.4. the appointment of a substitute decision-maker (secondary outcome at patient level)
1.5. GP self-confidence for conducting ACP, attitudes and knowledge about ACP (secondary outcomes at GP level)
1.6. the documentation of ACP discussions in the patient medical file (secondary outcome at GP level)
1.7. the surrogate decision maker’s level of engagement with ACP (secondary outcome at surrogate decision maker level)
2. To evaluate the recruitment and implementation process of the intervention in terms of its reach, efficacy, adoption, implementation, and maintenance, as reported by patients, their surrogate decision maker if they are present, and GPs; by means of a process evaluation running parallel with the study

Ethics approval

Approved 18/03/2020, Commission for Medical Ethics (O.G. 016) of the Vrije Universiteit Brussel/UZ Brussel (Laarbeeklaan 101, 1090 Brussels, Belgium; + 32 (0)2 477 55 84; commissie.ethiek@uzbrussel.be), ref: 2020/068

Study design

Multicenter cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic, life-limiting illnesses (cancer, heart failure, kidney failure, severe COPD, and mild to severe geriatric frailty)

Intervention

An independent statistician not affiliated with the research group will randomize the participating general practitioners (GPs) along with their patient cluster to the intervention or control group. Randomization occurs at the GP level to prevent contamination between the intervention and control group, as all patients within one cluster will receive either consultations from a GP who has received the intervention, or care as usual from a GP who did not receive the intervention.

The control group GPs will provide their included patients with the usual standard of care, which may or may not include spontaneous ACP discussions according to the GP’s judgment. No additional materials will be provided and no additional GP appointments will be required.

The intervention consists of following components for 6 months:
1. An advance care planning (ACP) training for GPs, where GPs can practice ACP conversations with feedback
2. An ACP workbook for patients called "Mijn Wensen Voor Toekomstige Zorg" (My Wishes for Future Care) which encourages reflection about what the patient considers a good quality of life and quality of care
3. At least 2 ACP conversations between the GP and patient, using materials such as a conversation guide for GPs (provided during the training) and the patient's workbook
4. Documentation of the ACP conversation outcomes in a standardized template

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Level of engagement with advance care planning will be measured using the 15-item version of the ACP Engagement Survey (Dutch translation) at baseline, 3 months, and 6 months
2. The general practitioner primary outcome of advance care planning self-efficacy will be measured using the ACP Self-Efficacy Scale (ACP-SE) at baseline, 3 months, and 6 months.

Secondary outcome measures

1. Patient health-related quality of life measured using the 12-item Short-Form Survey (SF-12) at baseline, 3 months, and 6 months
2. Patient anxiety measured using the Generalized Anxiety Disorder (GAD-7) Questionnaire at baseline, 3 months, and 6 months
3. Patient depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3 months, and 6 months
4. Appointment of a substitute decision maker will be evaluated by GP report, and by the response to the ACP engagement survey “readiness to sign official papers assigning a SDM” item, at baseline, 3 months, and 6 months
5. Completion of new advance care planning documents will be evaluated by patient report, GP report, and ACP engagement survey “readiness to sign official papers stating medical wishes” item, at 3 months and 6 months
6. General practitioner knowledge, attitudes, and self-confidence regarding advance care planning measured using the Next Steps training program questionnaire, at baseline, 3 months, and 6 months
7. Documentation of ACP discussion outcomes evaluated through anonymized documentation template review, at 3 months and 6 months
8. Surrogate decision maker level of engagement with advance care planning measured using the ACP Engagement Survey, substitute decision maker version (Dutch translation) at baseline, 3 months, and 6 months
9. Process outcome measures (RE-AIM framework) evaluated through general practitioner focus group discussions at 6 months
10. Process outcome measures (RE-AIM framework) evaluated through semi-structured interviews with patients and surrogate decision makers at 6 months

Overall trial start date

31/10/2019

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

General practitioners:
1. Dutch-spreaking
2. Working with and caring for patients in Flanders or Brussels, Belgium
3. Able to include at least 3 patients

Patients:
1. Adults (>18 years old)
2. Mentally competent as measured by judgment of the GP OR if Mini-Mental State Examination has been conducted, score is >24
3. GP answers "no" to the surprise question, "Would I be surprised if this patient were to die within the next 12 to 24 months?"
4. Diagnosis of a life-limiting illness:
4.1. Locally-advanced unresectable, or metastasized cancer OR
4.2. Organ failure, this being
a) heart failure (New York Heart Association stage 3 or stage 4)
b) chronic kidney failure or end-stage renal disease (ESRD) (stage 4, eGFR=15-29;
or stage 5, eGFR<15)
c) Very severe COPD (GOLD COPD stages stage 3 or stage 4) OR
OR
4.3. Geriatric frailty (Clinical Frailty Scale score 5-7, mildly to severely frail)

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

36 general practitioners, each with a cluster of 3 patients (108 patients total), up to 108 surrogate decision makers (1 per patient)

Participant exclusion criteria

General practitioners:
1. Participated in Phase-II trial of the intervention
2. Participated in the cognitive testing of intervention materials and translated questionnaires

Patients:
1. Unable to speak or understand Dutch
2. Unable to provide consent or complete the questionnaires due to cognitive impairment
3. GP answers "no" to the surprise question, "Would I be surprised if this patient were to die within the next 6 months?"
4. Participated in the phase-II trial of this intervention
5. Participated in the cognitive testing of intervention materials and translated questionnaires

Recruitment start date

30/06/2020

Recruitment end date

30/11/2020

Locations

Countries of recruitment

Belgium

Trial participating centre

Vrije Universiteit Brussel
Laarbeeklaan 101
Jette
1090
Belgium

Trial participating centre

Universiteit Gent
Campus UZ Gent C. Heymanslaan 10
Gent
B-9000
Belgium

Sponsor information

Organisation

Vrije Universiteit Brussel

Sponsor details

Laarbeeklaan 103
Jette
1090
Belgium
+32 24774757
info@vub.ac.be

Sponsor type

University/education

Website

http://www.vub.ac.be/en/

Funders

Funder type

Government

Funder name

Fonds Wetenschappelijk Onderzoek

Alternative name(s)

Research Foundation Flanders, Flemish Research Foundation, FWO

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Belgium

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The findings from this study are planned to be published in at least 4 research articles.

The datasets generated during and/or analysed during the current study will be available upon request. Requests may be addressed to the main contact persons (Julie Stevens, Prof. Koen Pardon, Dr. Aline De Vleminck, Prof. Luc Deliens). Every request will be evaluated on an individual basis and the ethics committee of the Vrije Universiteit Brussels will be contacted for approval before any sharing of participant-level data.

Intention to publish date

31/03/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/06/2020: Internal review. 19/06/2020: Trial’s existence confirmed by FWO ethics committee.